The Impact of Japan’s Positive List Reorganization on Food Contact Compliance
Japan’s Positive List (PL) system for food contact materials continues its evolution in 2023. In 2018, Japan amended the Food Sanitation Act and implemented a mandatory PL system for synthetic resin Food Contact Materials (FCM). Originally, the PL structure for synthetic resins consisted of separate tables for polymers, “minor” or trace monomers, coatings, and additives. Japan has revised the PL several times since it was first issued in 2020. In April 2022, Japan issued a new proposed draft of the PL which included a major reorganization.
This 2022 reorganization in April 2022 adjusted the PL tables to remove the table for minor monomers, as monomers used at less than 2% of the polymer were no longer required to be listed on the PL. The previously separate tables for polymers and coatings were condensed into one table, which was restructured to list essential monomers and optional substances to be used for each polymer type. Another substantive change was the exemption of naturally occurring substances, such as titanium dioxide or starch, from having to be listed on the PL. In addition, the restrictions on the previous PL concerning food type and usage temperatures were lifted. There continues to be a general safety provision, tasking manufacturers and importers with ensuring the safety of their FCM. Due to this, manufacturers and importers must notify downstream users of appropriate usage conditions, which may include temperature and food type restrictions.
Japan’s Ministry of Health, Labour and Welfare (MHLW) most recently issued a new draft of table 1 for polymers on 26 December 2022, which was revised based on industry comments on the April 2022 proposed draft tables. A revised draft of table 2 for additives is anticipated to be released in early 2023. The proposed drafts are not yet in force, and until they are implemented, the 24 December 2021 PL tables should be consulted for verifying compliance with Japan’s food contact regulations.
Information sharing along the supply chain continues to be mandatory, confirming compliance with the relevant regulation and conveying any limitations on the FCM. There is a 5-year grace period to continue manufacturing and marketing products in Japan which are comprised of FCMs that are not compliant with the PL but have been on the market in Japan prior to 1 June 2020. This grace period lasts until 31 May 2025 and this grace period was not extended with the recent revisions. There is an option to submit an authorization dossier to Japan’s regulators to request that an unlisted food contact substance be assessed by the MHLW for inclusion on the PL tables.
To ensure that your Food Contact Materials meet Japan’s latest regulatory requirements and to assist in the process of submitting an authorization dossier for the inclusion of a Food Contact Substance on the Japanese PL, please contact the knoell FFCM team here.